large simple placebo controlled trial, among adults with head injury
and impaired consciousness, of the effects of a 48 hour infusion of
corticosteroids on death and neurological disability.
Worldwide, millions of people are treated each year for severe head injury. A substantial proportion die, and many more are permanently disabled. If short term corticosteroid infusion could be reliably shown to reduce these risks by just a few percent then this might affect the treatment of a few hundred thousand patients a year, protecting thousands from death or long term disability.
When all previous trials of steroids in head injury are combined, the risk of death in the corticosteroid treated group appears to be about 2% lower than in the control group, but the 95% confidence interval runs from 6% lower to 2% higher mortality. Thus, the overall result is compatible with there being no benefit, but is also easily compatible with a benefit of a few percent. The CRASH trial will determine reliably the effects on death and on disability of a short term corticosteroid infusion following significant head injury.
To detect or refute
improvements of only a few percent in outcome, many thousands of acute
head injury patients must be randomised between control and steroid
infusions. Such large numbers will be possible only if hundreds of doctors
and nurses can collaborate in the participating emergency departments.
Since they are busy, and working in emergency situations, the trial
involves them in almost no extra work: no special investigations or
changes to usual management are required, and data collection is absolutely
minimal. Patients participating in this trial are not precluded from
enrolment in other trials.
|CRASH will determine reliably the effects of corticosteroids on death and on disability following significant head injury
One single-sided outcome form, completed from hospital notes (at discharge, death in hospital, or two weeks from injury, whichever occurs first).